Advances in contact lens materials to extend wear time for a new standard in vision correction and future medical devices

隐形眼镜材料的进步可延长佩戴时间，从而达到视力矫正和未来医疗设备的新标准

• 批准号: 9255935
• 负责人: Roman Domszy
• 金额: $ 22.5万
• 依托单位: INDUSTRIAL SCIENCE & TECHNOLOGY NETWORK
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255935
• 关键词: 3-Dimensional; Acanthamoeba Keratitis; Address; Adolescent; Adverse effects; Affect; Appearance; Area; Astigmatism; Blood capillaries; Clinical Research; Complex; Contact Lenses; Convection; Cornea; Corneal Topography; Cosmetics; Devices; Dimensions; Drug Delivery Systems; Drug Monitoring; Dryness; Elderly; Emerging Technologies; Engineering; Environment; Eyeglasses; Film; Future; Gases; Generations; Glaucoma; Goals; Growth Factor; Health; Health Care Costs; Hormones; Hydrogels; Hydrophilic Contact Lenses; Hydrophobicity; Hyperopia; Hypoxia; Image; Infection; Inflammation; Laser In Situ Keratomileusis; Lead; Long-Term Effects; Measurable; Measures; Medical Device; Methods; Modality; Molds; Molecular Conformation; Monitor; Morphology; Myeloma Proteins; Myopia; Nanotechnology; Needles; Nutrient; Operative Surgical Procedures; Optics; Optometry; Oxygen; Patients; Peptides; Performance; Permeability; Phase; Photorefractive Keratectomy; Polymers; Polynomial Models; Population; Presbyopia; Printing; Problem Solving; Process; Production; Property; Proteins; Redness; Risk; Shapes; Silicon; Silicones; Structure; Surface; Surface Tension; Technology; Time; Vision; Visual; Visual Acuity; Water; antimicrobial drug; base; biomaterial compatibility; capillary; commercialization; copolymer; cost; design; improved; innovation; lens; molecular assembly/self assembly; monitoring device; novel; patient population; prototype; submicron; surface coating; surfactant; wasting

PROJECT SUMMARY Over the last two decades, the commercialization of silicone-hydrogel ("SiHy") composite technologies has led to new soft CLs that are more breathable, comfortable, and affordable, including in daily disposable versions which have considerably broadened the customer base, especially among younger generations. Despite these improvements, the major persistent problem facing contact lenses is their poor compatibility with ocular environment, particularly the tear film. While the softness of the new composite materials made lenses more comfortable by conforming better to the cornea, the resultant tight fitting considerably lowers the tear exchange rate in the post-lens tear film. In addition, the precision of lens design and fabrication, limited by the difficulties of the thermal expansion of a dual-domain (silicon and hydrogel) substrate, are adequate only for adjusting an image's focus, not its visual acuity caused by other higher- order optical aberrations. We propose to solve these issues by creating a novel contact lens material that will lead to a new best-in-class soft lens with significant improvements in vision correction, clarity and comfort, and wide applicability to numerous patient populations. This project will engineer the new generation of lens innovations based on several recent advances in material and fabrication nanotechnologies. The combined application of submicron morphology control, molecular self-assembly, and high-precision molding (as well as 3-D printing), will make future CL devices more precise, biocompatible, and versatile. We identified three major areas of improvement in CLs that will benefit from our implementation of such new emerging technologies: (a) Pre-synthesis of new silicone block-copolymers for higher-precision control of domain morphology during lens fabrication, (b) Application of high-precision fabrication and high-definition ("HD") design for correcting the spherical aberration of CLs, and (c) Engineering a novel design of lens material and surface coating for enhancing PLTF turnover to improve ocular health. The new product would widely replace current CLs for at least the 39 million patients in the US market, and likely expand this market significantly with new and valuable functions such as control of myopia progression for adolescents and night vision enhancements for the elderly (by high-precision control and high-definition design), as well as unprecedented comfort and biocompatibility (by new surface coating's enhancement of PLTF turnover). Further, the new level of comfort and extended wear time would solve one key challenge associated with current state-of-the-art in ocular drug delivery and monitoring devices, promoting our technology to a future platform for growing these applications to treat other large populations such as the 64 million glaucoma patients worldwide.

项目总结 在过去的二十年里，有机硅-水凝胶(SiHy)复合技术的商业化导致了新的 更透气、更舒适、更实惠的柔软CLS，包括具有以下特性的日常一次性版本 大大扩大了客户基础，特别是在年轻一代中。尽管有这些改进， 隐形眼镜面临的主要长期问题是它们与眼睛环境的兼容性很差，特别是 催泪片。而新型复合材料的柔软性使镜片更舒适，因为它更符合 角膜，由此产生的紧密配合，大大降低了晶状体后泪膜中的泪液交换率。此外, 透镜设计和制造的精确度，受到双域(硅)热膨胀困难的限制 和水凝胶)衬底，只适合于调整图像的对焦，而不是由其他较高的 对光学像差排序。我们建议通过创造一种新的隐形眼镜材料来解决这些问题，这种材料将导致 一款新的同类最佳软性镜头，在视力矫正、清晰度和舒适性方面都有显著改进，并且 适用于众多患者群体。 该项目将基于材料和技术方面的几个最新进展设计新一代透镜创新 制造纳米技术。亚微米形态控制、分子自组装、 和高精度成型(以及3D打印)，将使未来的CL设备更精确，更生物兼容，以及 多面手。我们确定了CLS的三个主要改进领域，这些领域将受益于我们实施这种新的 新兴技术：(A)预合成新的有机硅嵌段共聚物，以实现更精确的结构域控制 透镜制造过程中的形态，(B)高精度制造和高清晰度(HD)设计的应用 (C)设计了一种新的透镜材料和表面镀膜。 提高PLTF的周转率，改善眼部健康。 这款新产品将广泛取代目前的CLS，覆盖美国市场上至少3900万患者，并有可能 通过控制青少年近视进展等新的有价值的功能显著扩大这一市场 老年人夜视增强(通过高精度控制和高清晰度设计)以及 前所未有的舒适性和生物兼容性(通过新的表面涂层提高PLTF周转率)。此外， 新的舒适度和更长的穿戴时间将解决与当前最先进的技术相关的一个关键挑战 在眼科药物输送和监测设备方面，将我们的技术推广到未来的平台，以实现这些 应用于治疗其他大量人群，如全球范围内的百万青光眼患者。